"Pharmaceutical Industry Involvement in Medical Education"
Pharmaceutical Industry Involvement in Medical Education Mark R. Tonelli, MD MA Associate Professor of Medicine Adjunct Associate Professor of Medical History and Ethics University of Washington Pharmaceutical and Medical Device Industries For proﬁt corporations – Primary duty to shareholders – Maximize shareholder value Value of speciﬁc product – Pricing – Utilization Indications Market share Clinical Medicine Duty to individual patient – Maximizing medical beneﬁt – Avoiding harm Duty to society – Judicious use of limited resources – Less emphasized in US care structure Industry/Clinician Interactions Historically – Personal relationships between rep/physician Trinkets, gifts, meals and travel Detailing – “Consulting” fees, “focus group” participation Quite effective in changing physician behavior. Industry/Clinician Interactions Historical practices under scrutiny – Public backlash Related in part to drug costs – Professional organizations American Medical Student Association – Academic institutions/Practice groups Conﬂict of interest policies – PHARMA Guidelines – IOM report Industry and Continuing Medical Education With constraints upon marketing, industry redeﬁning role as one of “medical education.” Role of pharma rep as medical educator (with narrow range of expertise). Increased reliance upon (selected) published research in detailing. Industry and Continuing Medical Education Industry sponsorship/underwriting of CME activities rising rapidly. – >$1.1billion investment in 2005. – Represents 2/3 of total CME expenditures Virtually all physicians, many other clinicians statutorily required to accrue CME hours for relicensure. – Ensures market for and attendance at CME Continuing Medical Education Providers of CME must be accredited by the Accreditation Council for Continuing Medical Education (ACCME) ACCME has certiﬁed numerous private, for-proﬁt medical education and communication companies (MECCs) – May present accredited CME programs. – Almost all underwritten by industry. Continuing Medical Education Relationship between industry and MECCs allows for topic, content, speakers of a CME activity to be dictated by industry. Rules established by ACCME require nominal independence from industry – “Unrestricted” educational grants – Disclosure of speaker relationships with industry Clinical Practice Guidelines Guideline development – Potential to drive change in practice May be underwritten by industry – Conﬂicts of interest of developers very common – May be expected to produce guidelines that increase use of a particular product ACCP guidelines on DVT/PE (LMWH makers) Surviving Sepsis Campaign (Eli Lilly) Ethical Issues in Industry Supported CME Contribution of industry to CME not necessarily unethical. Pharma beneﬁts from clinical practice, contribution to CME could be seen as an obligation or, at least, morally defensible. Ethical conﬂict arises when industry uses CME to shape physician practice in a way more likely to beneﬁt the industry than the individual patient. Effects of Industry-sponsored CME Support limits topics presented – Focus on new interventions – Few discussions of generic therapies, non- pharmaceutical options Alters subsequent physician behavior in manner consistent with sponsorʼs interest Katz HP; J Contin Educ Health Prof 2002 Bowman MA; J Contin Educ Health Prof 1988 Continuing Medical Marketing Marketing vs. Medical education – Industry participation in CME blurs this distinction. – Call for absolute ban Industryparticipation makes CME marketing Physicians should bear cost of own CME – Call for tighter regulation Truly make CME grants unrestricted. The Future of CME United States Senate – Proposed hearing regarding commercial inﬂuence in CME – Has requested and received information from ACCME – Hearing has been delayed due to other more pressing considerations Grassley/Kohl bill to require disclosure of all physician payments from industry, including honoraria for CME. The Future of CME ACCME Board of Directors (March, 09) – Will take no action on call to eliminate industry support of CME – Will consider allowing designations of “Commercial Support Free”™ “Promotional Teacher and Author Free”™ – Will consider creation of a central repository for industry contributions to CME The Future of CME Institute of Medicine Report on Conﬂicts of Interest in Medical Research, Education and Practice. Recommends: – “broad-based consensus process to develop a new system for funding high- quality accredited continuing medical education that is free of industry inﬂuence.” – Notes higher costs for physicians.